M2HepPrEP: study protocol for a multi-site multi-setting randomized controlled trial of integrated HIV prevention and HCV care for PWID

Martel-Laferrière, Valérie; Feaster, Daniel J.; Metsch, Lisa R.; Shackman, Bruce R; Loignon, Christine; Nosyk, Bohdan; Tookes, Hansel; Behrends, Czarina N.; Arruda, Nelson; Adigun, Oluleye; Goyer, Marie-Ève; Kolber, Michael A.; Mary, Jean-Francois; Rodríguez, Allan; Yanez, Iveth G.; Pan, Yue; Khemiri, Rania; Gooden, Lauren; Sako, Aïssata; Bruneau, Julie

doi:10.1186/s13063-022-06085-3

Cited by 5 publications

(6 citation statements)

References 100 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The I Test project is one of the first comprehensive studies to develop and test a PC intervention to support the adoption and implementation of HIV and HIV testing in opioid treatment programs. It is also novel in that it employs a study design that accounts for the integration of HIV and HCV testing in treatment programs, with a focus on linkage to care [ 35 ]. Additionally, the translation of findings from this study is central and is supported by the cost analysis.…”

Section: Discussionmentioning

confidence: 99%

A study protocol for Project I-Test: a cluster randomized controlled trial of a practice coaching intervention to increase HIV testing in substance use treatment programs

Frimpong,

Parish,

Feaster

et al. 2023

Trials

Self Cite

View full text Add to dashboard Cite

Background People with substance use disorders are vulnerable to acquiring HIV. Testing is fundamental to diagnosis, treatment, and prevention; however, in the past decade, there has been a decline in the number of substance use disorder (SUD) treatment programs offering on-site HIV testing. Fewer than half of SUDs in the USA offer on-site HIV testing. In addition, nearly a quarter of newly diagnosed cases have AIDS at the time of diagnosis. Lack of testing is one of the main reasons that annual HIV incidences have remained constant over time. Integration of HIV testing with testing for HCV, an infection prevalent among persons vulnerable to HIV infection, and in settings where they receive health services, including opioid treatment programs (OTPs), is of great public health importance. Methods/design In this 3-arm cluster-RCT of opioid use disorders treatment programs, we test the effect of two evidence-based “practice coaching” (PC) interventions on the provision and sustained implementation of on-site HIV testing, on-site HIV/HCV testing, and linkage to care. Using the National Survey of Substance Abuse Treatment Services data available from SAMHSA, 51 sites are randomly assigned to one of the three conditions: practice coach facilitated structured conversations around implementing change, with provision of resources and documents to support the implementation of (1) HIV testing only, or (2) HIV/HCV testing, and (3) a control condition that provides a package with information only. We collect quantitative (e.g., HIV and HCV testing at 6-month-long intervals) and qualitative site data near the time of randomization, and again approximately 7–12 months after randomization. Discussion Innovative and comprehensive approaches that facilitate and promote the adoption and sustainability of HIV and HCV testing in opioid treatment programs are important for addressing and reducing HIV and HCV infection rates. This study is one of the first to test organizational approaches (practice coaching) to increase HIV and HIV/HCV testing and linkage to care among individuals receiving treatment for opioid use disorder. The study may provide valuable insight and knowledge on the multiple levels of intervention that, if integrated, may better position OTPs to improve and sustain testing practices and improve population health. Trial registration ClinicalTrials.gov NCT03135886. Registered on 2 May 2017.

show abstract

Section: Discussionmentioning

confidence: 99%

A study protocol for Project I-Test: a cluster randomized controlled trial of a practice coaching intervention to increase HIV testing in substance use treatment programs

Frimpong,

Parish,

Feaster

et al. 2023

Trials

Self Cite

View full text Add to dashboard Cite

show abstract

“…Exclusion criteria include the following: (1) PWID with HIV; (2) currently on MOUD; (3) currently on PrEP; (4) principal or site investigator discretion; (5) currently in prison or jail; and (6) current enrollment in NIDA Clinical Trials Network (CTN) 121 which is a study that our team is leading in Miami to test a comprehensive, integrated hospital-based intervention to address concurrent treatment and follow-up support for PWID with severe infections; (7) current enrollment in M2HepPrEP (R01 DA045713) [ 52 ] which is an integrated Hepatitis C and HIV prevention study that our team is completing this year; (8) hepatitis B surface antigen positive; (9) receipt of THR in the previous 3 months; and (10) signs or symptoms of acute HIV infection. Investigator discretion could include serious medical, psychiatric, or co-occurring SUD that acutely requires a higher or different level of care including the following: (1) disabling or terminal medical illness (e.g., decompensated heart failure); (2) severe, untreated or inadequately treated psychiatric condition (e.g., active psychosis); (3) in need of medical detoxification for severe alcohol, benzodiazepine, or other depressant or sedative hypnotic use; (4) suicidal intent or plan; and (5) homicidal ideation.…”

Section: Methods: Participants Interventions and Outcomesmentioning

confidence: 99%

Project CHARIOT: study protocol for a hybrid type 1 effectiveness-implementation study of comprehensive tele-harm reduction for engagement of people who inject drugs in HIV prevention services

Bartholomew,

Plesons,

Serota

et al. 2024

Addict Sci Clin Pract

Self Cite

View full text Add to dashboard Cite

Background People who inject drugs (PWID) remain a high priority population under the federal Ending the HIV Epidemic initiative with 11% of new HIV infections attributable to injection drug use. There is a critical need for innovative, efficacious, scalable, and community-driven models of healthcare in non-stigmatizing settings for PWID. We seek to test a Comprehensive-TeleHarm Reduction (C-THR) intervention for HIV prevention services delivered via a syringe services program (SSP). Methods The CHARIOT trial is a hybrid type I effectiveness-implementation study using a parallel two-arm randomized controlled trial design. Participants (i.e., PWID; n = 350) will be recruited from a syringe services program (SSP) in Miami, Florida. Participants will be randomized to receive either C-THR or non-SSP clinic referral and patient navigation. The objectives are: (1) to determine if the C-THR intervention increases engagement in HIV prevention (i.e., HIV pre-exposure prophylaxis; PrEP or medications for opioid use disorder; MOUD) compared to non-SSP clinic referral and patient navigation, (2) to examine the long-term effectiveness and cost-effectiveness of the C-THR intervention, and (3) to assess the barriers and facilitators to implementation and sustainment of the C-THR intervention. The co-primary outcomes are PrEP or MOUD engagement across follow-up at 3, 6, 9 and 12 months. For PrEP, engagement is confirmed by tenofovir on dried blood spot or cabotegravir injection within the previous 8 weeks. For MOUD, engagement is defined as screening positive for norbuprenorphine or methadone on urine drug screen; or naltrexone or buprenorphine injection within the previous 4 weeks. Secondary outcomes include PrEP adherence, engagement in HCV treatment and sustained virologic response, and treatment of sexually transmitted infections. The short and long term cost-effectiveness analyses and mixed-methods implementation evaluation will provide compelling data on the sustainability and possible impact of C-THR on comprehensive HIV prevention delivered via SSPs. Discussion The CHARIOT trial will be the first to our knowledge to test the efficacy of an innovative, peer-led telehealth intervention with PWID at risk for HIV delivered via an SSP. This innovative healthcare model seeks to transform the way PWID access care by bypassing the traditional healthcare system, reducing multi-level barriers to care, and meeting PWID where they are. Trial Registration: ClinicalTrials.gov NCT05897099. Trial registry name: Comprehensive HIV and Harm Prevention Via Telehealth (CHARIOT). Registration date: 06/12/2023.

show abstract

“…For the present study, an attempt to re-contact these individuals were made via email and telephone, and similar recruitment methods were implemented to recruit additional participants to replenish the sample of individuals who were not able to be re-contacted and were lost to follow-up. Francophone participants were recruited from a pre-existing cohort (HEPCO Cohort) of injection drug users with a history of HIV and/or HCV infection, residing in the greater Montreal area (Research Ethics Board (#20.053) [ 39 ]. A French speaking member of our research team at the Centre Hospitalier de l’Universite de Montreal (CHUM) in Quebec contacted participants via telephone, informed them of the study, gauged study interest, and conducted informed consent and the interview with interested participants.…”

Section: Methodsmentioning

confidence: 99%

Identifying barriers and facilitators to COVID-19 vaccination uptake among People Who Use Drugs in Canada: a National Qualitative Study

et al. 2023

Self Cite

View full text Add to dashboard Cite

Background People Who Use Drugs (PWUD) have lower vaccination uptake than the general population, and disproportionately experience the burden of harms from vaccine-preventable diseases. We conducted a national qualitative study to: (1) identify the barriers and facilitators to receiving COVID-19 vaccinations among PWUD; and (2) identify interventions to support PWUD in their decision-making. Methods Between March and October 2022, semi-structured interviews with PWUD across Canada were conducted. Fully vaccinated (2 or more doses) and partially or unvaccinated (1 dose or less) participants were recruited from a convenience sample to participate in telephone interviews to discuss facilitators, barriers, and concerns about receiving COVID-19 vaccines and subsequent boosters, and ways to address concerns. A total of 78 PWUD participated in the study, with 50 participants being fully vaccinated and 28 participants partially or unvaccinated. Using thematic analysis, interviews were coded based on the capability, opportunity, and motivation-behavior (COM-B) framework. Results Many partially or unvaccinated participants reported lacking knowledge about the COVID-19 vaccine, particularly in terms of its usefulness and benefits. Some participants reported lacking knowledge around potential long-term side effects of the vaccine, and the differences of the various vaccine brands. Distrust toward government and healthcare agencies, the unprecedented rapidity of vaccine development and skepticism of vaccine effectiveness were also noted as barriers. Facilitators for vaccination included a desire to protect oneself or others and compliance with government mandates which required individuals to get vaccinated in order to access services, attend work or travel. To improve vaccination uptake, the most trusted and appropriate avenues for vaccination information sharing were identified by participants to be people with lived and living experience with drug use (PWLLE), harm reduction workers, or healthcare providers working within settings commonly visited by PWUD. Conclusion PWLLE should be supported to design tailored information to reduce barriers and address mistrust. Resources addressing knowledge gaps should be disseminated in areas and through organizations where PWUD frequently access, such as harm reduction services and social media platforms.

show abstract

M2HepPrEP: study protocol for a multi-site multi-setting randomized controlled trial of integrated HIV prevention and HCV care for PWID

Cited by 5 publications

References 100 publications

A study protocol for Project I-Test: a cluster randomized controlled trial of a practice coaching intervention to increase HIV testing in substance use treatment programs

A study protocol for Project I-Test: a cluster randomized controlled trial of a practice coaching intervention to increase HIV testing in substance use treatment programs

Project CHARIOT: study protocol for a hybrid type 1 effectiveness-implementation study of comprehensive tele-harm reduction for engagement of people who inject drugs in HIV prevention services

Identifying barriers and facilitators to COVID-19 vaccination uptake among People Who Use Drugs in Canada: a National Qualitative Study

Contact Info

Product

Resources

About